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    K Number
    K964690
    Device Name
    LIBERTY VALVE
    Manufacturer
    CLEVELAND MEDICAL DEVICES, INC.
    Date Cleared
    1997-03-21

    (119 days)

    Product Code
    KNX
    Regulation Number
    876.5250
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIBERTY VALVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.

    Device Description

    The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    Electrical Stability/Current LeaksNo potential (relative to negative terminal) and no current leaks should be exhibited in a worst-case scenario (supersaturated salt water solution). Absence of electrical activity in the solution should confirm electrical stability.Tested in a supersaturated salt water solution for 2.5 hours with continuous flushing.
    Results: No potential exhibited and no current leaks (0 A, 0 V) at 3, 13, 30, and 150 minutes, both in the solution and on the surface.
    This result was attributed to the use of a septum and o-ring at the valve/connector interface, confirming electrical stability.
    Drainage TimeThe valve should effectively drain a urine collection bag. (Implicitly, within a reasonable timeframe, given the comparison to existing devices).Bench Testing:
    • At 0 °C: 1 minute 53 seconds to drain 500 mL.
    • At 23 °C: 1 minute 49 seconds to drain 500 mL.
    • At 70 °C: 1 minute 45 seconds to drain 500 mL.
      All tests drained 500 mL from a urine collection bag held ten inches above the valve in less than two minutes. |
      | Operating Temperature Range | The device should operate effectively across a suitable temperature range. | Tests conducted at 0 °C, 23 °C, and 70 °C showed the valve required less than two minutes to drain 500 mL at all these temperatures.
      Recommended: Use at temperatures between 0 °C and 70 °C. |

    Note regarding Acceptance Criteria: The provided document does not explicitly state numerical acceptance criteria for current leaks (e.g., "current leaks must be

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